Description
Drug Facts
Exemax Cream
FDA Label NDC 59088-212
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Puretek Corporation for the product Exemax Cream (NDC 59088-212). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, active ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor if, do not use on, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Dimethicone 5%
Allantoin 2%
Purpose
Skin Protectant
Uses
● temporarily protects and helps relieve chapped or cracked skin
● helps protect from the drying effects of wind and cold weather
Warnings
● For external use only
When Using This Product
● do not get into eyes.
Stop Use And Ask A Doctor If
● condition worsens
● symptoms last more than 7 days or clear up and occur again within a few days
Do Not Use On
● deep or puncture wounds
● animal bites
● serious burns
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
● apply as needed
Other Information
● Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]
Inactive Ingredients:
Aqua (Purified Water), Arnica Montana (Arnica) Flower Extract, Avena sativa (Oat) Kernel Flour, Bisabolol, Calcium Pantothenate (Vitamin B5), Carthamus tinctorius (Safflower) Oleosomes, Centella Asiatica (Asiatic Pennywort) Extract, Citric Acid, DL-Alpha-Tocopheryl Acetate (Vitamin E), Ethylhexylglycerin, Glycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Inositol, Lactic Acid, Maltodextrin, Niacinamide (Vitamin B3), Phenoxyethanol, Polyacrylate Crosspolymer-6, Pyridoxine HCl (Vitamin B6), Saccharide Isomerate, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Citrate, Sodium Hyaluronate, Sodium Hydroxide, Sodium Starch Octenylsuccinate, Tetrahexyldecyl Ascorbate, Zingiber Officinale (Ginger) Root Extract.
Exemax™ Cream
Manufactured by:
PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free:
877-921-7873
Label (Label)
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